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Job Description

About the role:

The Associate Director, Medical Information and Review, will serve as a functional expert in the area of Medical Review for their assigned region and products and ensure alignment and integration of process and technology efficiencies in medical review and information activities across diseases areas for Global Medical Affairs Oncology (GMAO).

The individual in this role must excel in providing advanced medical and scientific review of commerical and medical affairs materials (promotional and non promotional materials) to support the non-promotional and promotional review processes. The Individual in this role will be responsible for performing timely, accurate and detailed scientific/medical review of non-promotional and promotional materials for the US and Global market in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. He/she ensures Takeda non-promotional/ promotional materials convey accurate, correct and balanced medical/ scientific messages.

In addition, will be required to partner with the Head of Medical information and Review to deliver as needed high-quality, balanced and timely medical and scientific information deliverables for assigned products upon request from internal and external business partners, health care professionals (HCPs) and consumers. They must provide advanced medical information / clinical expertise for assigned products to internal stakeholders (eg, medical affairs strategy teams, product teams within R&D, commercial Brand teams) and external stakeholders (eg, HCPs, patients and advocacy groups).

Lastly, this individual may be required to support Medical Information and Review needs and activities for other brands and pipeline products, as well as above brand activities, to ensure a best in class Medical Information and Review function, ensuring Takeda Oncology’s professional standing and integrity with patients, HCPs and the pharmaceutical industry through high-quality and aligned medical information and communication.

How you will contribute:

• Provide advanced medical and scientific review of medical affairs materials and, if required, promotional materials to support non-promotional and promotional review processes, as well as providing project management support for the medical review process, as needed.
• Provide advanced medical and scientific review of promotional and promotional materials with local and regional Regulatory codes applicable for the US region in mind. Experience with the ABPI, EFPIA, and EMEA codes is optional for this role.
• Utilizing advanced medical information /clinical expertise, independently oversee, plan, develop, maintain and provide high-quality, balanced and timely medical and scientific information deliverables including Standard and Custom Response Letters, Global Core Response Documents, Clinical Dossiers, and FAQs, to both internal and external customers.
• Provide guidance and direction to the Medical Information Call Center staff on handling routine and complex cases; monitor and manage complex escalated cases from the Medical Information Contact Center.
• Develop and deliver ongoing Medical Review and MLR process training for internal groups and medical affairs teams to ensure compliance with policies and procedures.
• Ensure content is well-substantiated by scientific data (verifying the content is accurately cited/properly referenced); check authenticity and validity of references; determine that references in promotional materials specifically support product claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claim(s) in the material.
• Conduct strategic assessment (gap analysis) of medical information needs within therapeutic areas and develop fulfillment strategies. As a result, plan the development of global core response documents (GCRDs) that are strategically aligned with regional and local needs, and partner with Global Medical Leads, as appropriate, to ensure approval of GCRDs.
• Develop content for the medical affairs booth in collaboration with GMAO stakeholders, as well as supporting third-party vendors. Provide advanced support to product booths at professional scientific meetings and congresses as appropriate. Participate in booth design and congress activities as required.
• Serve as the Medical Information and Review subject matter expert on the Global Medical Strategy Team Oncology (GMSTO) meetings for the relevant products/ therapeutic areas.
• Design and implement internal communication plans to share metrics and inform medical strategies by disseminating actionable medical insights and trends on a consistent basis. Lead the development and maintenance of departmental procedural guidelines and SOPs.
• Coach and mentor interns, fellows, students and Medical Information & Review team members.

Minimum Requirements/Qualifications:

• Bachelor’s degree in a scientific discipline plus commensurate long-term experience within pharmaceutical or biotech industry with a thorough grasp of the pharmaceutical industry
• 5+ years of healthcare or related experience (managed markets, clinical practice, research or academic) including 3+ years of medical information and review experience within the pharmaceutical industry
• Excellent written and oral communication skills
• Advanced PC skills, including MS Word, Excel, Power Point, and SharePoint
• Experience overseeing and managing budgets to ensure performance versus targets
• Oncology experience strongly preferred
• Firm understanding of pharmaceutical clinical development and product life cycle management
• Cross-functional team participation within the pharmaceutical or related industry

Preferred Requirements/Qualifications:

• Advanced degree (PhD, PharmD or equivalent) in a scientific discipline is preferred
• Oncology experience strongly preferred

What Takeda can offer you:

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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